Illegal drug residues in dairy cows slaughtered for meat were the main problem cited in recent warning letters from the U.S. Food and Drug Administration (FDA) to firms found in violation of regulations stipulated by the Food, Drug and Cosmetic Act.
Letters to four dairy producers warned that illegal levels of antibiotics and anti-inflammatory drugs had been found in the muscles and edible tissues of cows sold by the companies for slaughter. Other problems identified in recently posted warning letters included improper handling of acidified foods, improper handling of low-acid canned foods, unsanitary production conditions and misbranding of infant formula.
The firms whose product contained illegal levels of drugs included El-Vi Farms, LLC and Reuben R. Zimmerman, both of New York, Kelly Hills Dairy Inc. of Kansas and Noel D. Elmore of Kentucky.
FDA wrote to El-Vi Farms of Newark, NY, notifying the firm that samples of uncooked edible kidney tissue from a cow it sold for slaughter as food contained 4.16 parts per million (ppm) of ceftiofur, an animal antibiotic. This level was more than ten times the acceptable limit of .4 parts per million for this drug in edible kidneys.
The agency also found that E-Vi was administering ceftifur to animals in doses not authorized by the drug label and that it was not keeping proper treatment records for its animals.
Reuben R. Zimmerman, owner of his company bearing the same name, was warned that a cow sold for slaughter from his dairy facility contained .63 ppm of penicillin in its edible kidney tissue (the acceptable limit is .05 ppm), 1.3 ppm of the anti-inflammatory flunixin in its liver tissue, where the limit of the drug is .125 ppm, and .0293 ppm of flunixin in the muscle tissue, which can’t contain more than .025 ppm.
The Zimmerman facility was also found to be administering penicillin in doses not approved by its labeling and not keeping proper medical treatment records for its animals.
In its letter to Kelly Hills Dairy, Inc. of Seneca, KS, FDA notified the company that penicillin residues of .515 ppm in uncooked edible tissues of a dairy cow sold for slaughter.
FDA wrote to Noel Elmore Farms of Glasgow, KY, that said the company had sold a dairy cow for slaughter for use as food whose tissue samples contained levels of penicillin at .215 ppm in its kidney (the legal limit is .05 ppm).
The FDA investigation also found that on July 5, 2011, the company wrote a letter certifying that it was not marketing livestock with illegal drug residues. That letter covered the dairy cow whose tissue was later found to contain illegal levels of penicillin.
FDA also told all companies whose dairy cows contained illegal drug levels that they were using doses of drugs beyond what has been approved by their labels.
“Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply,” said the agency to each of the firms.
FDA also wrote letters to other firms citing other food safety violations.
KIZ Foods Limited of Bhavnagar, India received a letter notifying it that it was not following regulations for the production of acidified foods.
Specifically, the company did not provide required records of its heat processing and control of pH, salt, sugar and preservative levels for its garlic past, ginger paste and ginger garlic paste to FDA. The firm also didn’t have personnel who have been certified in activities involving acidification, pH control, heat treatment and critical factors, another requirement.
FDA also found that KIZ did not conduct required pH testing, did not examine containers to make sure they are protected from contamination or leakage, did not mark product with a code identifying where and when it was produced, did not maintain equipment in a manner that will prevent it from contamination, did not clean food contact surfaces frequently enough and did not provide adequate hand washing facilities or hand drying stations for employees. Further, the firm did not take adequate steps to prevent pests from entering the facility and had not constructed its facility in a manner that allows for proper cleaning.
FDA wrote to Vella Cheese Company of Sonoma, CA, telling the company it had not followed proper production requirements for low-acid foods. Specifically, the company had not registered with FDA as a commercial processor of low-acid foods, had not notified FDA of its processing methods, including sterilization procedures and temperature controls.
“Scheduled processes must be established by qualified persons having expert knowledge acquired through appropriate training and experience in the thermal processing of low-acid foods in hermetically sealed containers,” wrote FDA in its letter.
Finally, FDA wrote to Nestle Infant Nutrition informing the company its Gerber Good Start Gentle Infant Formula is misbranded because it made health claims not authorized by FDA. The product’s label claimed it helped “reduce risk of developing allergies” and that the 100% whey partially hydrolyzed it contains may reduce the risk of atopic dermatitis, statements that were not authorized by FDA.
They agency said Nestle Infant Nutrition already submitted a petition requesting to assert a link between the whey product and a reduced risk of allergy in infants because there was not sufficient scientific evidence to support the claim. The agency also said there is no evidence linking the specific whey product in the formula to reduced risk of atopic dermatitis, only linking whey-protein to the condition.
FDA said the packaging failed to include the required statement, in bold type: “should not be fed to infants who are allergic to milk or to infants with existing milk allergy symptoms.”
All companies who received these recent warning letters were asked to respond to the letter within 15 working days outlining steps they will take to correct these violations.